EDF Health

Selected tag(s): Significant New Use Rule (SNUR)

EDF requests extension of illegally and unreasonably short comment period on proposed rule with incomplete docket

Richard Denison, Ph.D.is a Lead Senior Scientist.

Environmental Defense Fund (EDF) today submitted a request to the Environmental Protection Agency (EPA) to extend the mere 15-day period EPA has provided for public comments on a proposed modification to a Significant New Use Rule (SNUR).  The proposed SNUR modification was published in the Federal Register just last Thursday (February 8), and stated that comments must be received by February 23.

EPA must comply with its own requirements and provide electronic access to a public file containing all relevant documents prior to commencing at a minimum a 30-day comment period on this proposed rule.

EPA’s own regulations require EPA to provide the public with at least 30 days to comment on SNURs, see 40 CFR 721.160(c)(4) and 721.170(d)(4), making EPA’s 15-day comment period illegally short.

EDF requested that EPA provide at least 30 days for public comment – with that period to commence only after a complete public docket of relevant materials is made available by EPA.  As our request details, the docket EPA has provided for this proposed SNUR is woefully incomplete, missing even basic documents that preclude the public from being able to provide meaningful comments on the proposal.   Read More »

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EDF files extensive comments challenging EPA’s changes to new chemical reviews under TSCA

Richard Denison, Ph.D.is a Lead Senior Scientist.

This weekend EDF submitted detailed comments to the Environmental Protection Agency (EPA) on its implementation of changes to the New Chemicals Review Program, as well as comments responding to the agency’s draft New Chemicals Decision‐Making Framework.

After the passage of the Lautenberg Act in June 2016, EPA started out on a sound footing in implementing the major changes to Section 5 of the Toxic Substances Control Act (TSCA), correctly subjecting more new chemicals to conditions or testing requirements through issuance of consent orders.  It also took successful steps to address a temporary backlog that was largely due to the fact that these changes to TSCA took immediate effect.

Beginning in August of last year, however, using the already eliminated backlog as an excuse, the new political leadership at EPA signaled its intent to reverse course and effectively return the program to its pre-Lautenberg state – under which few chemicals were subject to any conditions and even fewer to any testing requirements, despite the fact that the great majority of new chemicals reviewed by EPA lack any health or environmental safety data.

EPA convened a meeting in early December of last year to present its New Chemicals Decision‐Making Framework implementing these changes.  The agency noted it was already using the Framework, despite also accepting comments on it.

EDF’s comments raise a host of legal, policy, scientific, good government and transparency objections to EPA’s new approach.  I won’t attempt to summarize the 42 pages of our comments here, many aspects of which we have raised through this blog over the past many months.

We hope EPA reconsiders its rash change of course and opts to comply with the law.

 

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EDF comments at EPA’s public meeting on new chemical reviews question the credibility and legality of recent changes

Richard Denison, Ph.D.is a Lead Senior Scientist.

EPA held a public meeting today to present information on major changes it is making to its review of new chemicals under last year’s reforms made to the Toxic Substances Control Act (TSCA) by the Lautenberg Act.

EPA provided brief opportunities for stakeholders to provide comments.  Two of us from EDF – I, and my colleague Robert Stockman, Senior Attorney – gave oral comments at the meeting.  We are providing those comments here in written form.

Through these actions, many clearly contrary to the law, EPA is returning the new chemicals program to its dark ages under the old TSCA, making it again into a black box within which EPA acts as if its only stakeholder is the chemical industry.

My comments are available here.

Robert Stockman’s comments are available here.

As the comments make clear, EDF believes the changes EPA is making and discussed today are both contrary to the requirements of the new TSCA and represent a retreat from the credible, transparent and accountable new chemicals program Congress sought to establish under the new law.

As I noted in my comments:  “Through these actions, many clearly contrary to the law, EPA is returning the new chemicals program to its dark ages under the old TSCA, making it again into a black box within which EPA acts as if its only stakeholder is the chemical industry.”

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Too little, too late: Why SNURs alone are not a sufficient alternative to consent orders for new chemicals

Richard Denison, Ph.D.is a Lead Senior Scientist.

The Environmental Protection Agency (EPA) is in the process of making some major changes to its policies and practices governing new chemical reviews.  This post discusses one of the most troubling ones.  

The SNUR-only approach EPA is now deploying differs dramatically from and provides far less risk protection than would result from it simply doing what the law requires:  using orders, with SNURs as backup.

As I have previously described, last year’s Lautenberg Act made extensive changes to section 5 of the Toxic Substances Control Act (TSCA), which governs the review of new chemicals prior to their manufacture and use.  Among these changes is a requirement that EPA must evaluate potential risks, and mitigate potential unreasonable risks, of a new chemical under its “conditions of use,” which the new law defines to include “reasonably foreseen” circumstances of production, processing, distribution, use or disposal, as well as those intended by the company submitting notice of the new chemical to EPA.  If EPA identifies potential risk or significant exposure or lacks sufficient information on a new chemical, it must issue an order prohibiting or limiting the conditions of use of the chemical in order to mitigate any unreasonable risk.

After passage of the Lautenberg Act until recently, and in keeping with the new law, if EPA’s review identified risk concerns relating to conditions of use beyond those strictly identified by a company submitting a new chemical notice to EPA, the agency made a “may present an unreasonable risk” finding and pursued development of a consent order with the company sufficient to ameliorate those concerns.  (While EPA has authority to issue unilateral orders, it typically negotiates with the company to arrive at a consent order that both parties sign.)

Now EPA is indicating it will instead make a “not likely to present an unreasonable risk” finding for the intended conditions of use, and says it can address any concerns over reasonably foreseen uses without issuing an order by developing only a significant new use rule (SNUR).  This “SNUR-only approach” is inconsistent with the law, a matter I won’t discuss further here.  However, it also raises a host of policy concerns, some of which I lay out in this post.

The SNUR-only approach EPA is now deploying differs dramatically from and provides far less risk protection than would result from it simply doing what the law requires:  using orders, with SNURs as backup.

There are ample reasons why Congress called on EPA to use orders to address concerns and then use SNURs as backup:  Orders (including consent orders) and SNURs are not created equal.  This post discusses 12 key differences, with respect to:

(Spoiler alert:  Deep dive ahead. Let me apologize to and warn readers in advance that this post gets rather into the weeds, as the issues are complicated and the details are important.)   Read More »

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EPA moves one step closer to managing risks from TCE

Lindsay McCormick is a Research Analyst.

It’s no secret that trichloroethylene (TCE) is a nasty chemical.  A 2013 review of thousands of scientific studies by Environmental Protection Agency (EPA) scientists concluded that TCE is carcinogenic to humans by all routes of exposure and poses additional hazards, including immunotoxicity, neurotoxicity, and adverse effects on the developing heart.  TCE’s link to cancer has been confirmed by the International Agency for Research on Cancer (IARC), EPA’s Integrated Risk Information System (IRIS),  the Agency for Toxic Substances and Disease Registry (ATSDR), and the National Toxicology Program (NTP).

With such a track record, one would expect that the U.S. government has restricted its use, right?  Wrong.  The current annual U.S. production of TCE is 250 million pounds – so, not surprisingly, human and environmental exposure is widespread.  While most TCE is used in industrial and commercial settings as a chemical intermediate in the production of other chemicals, it’s also commonly used as a metal degreasing agent and spot cleaner in commercial dry cleaning, and can be found in certain consumer products. Read More »

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A hint of movement in the Super Slo-Mo that is nanoregulation at EPA under TSCA

Richard Denison, Ph.D., is a Lead Senior Scientist.

Nearly 4 years ago, EPA sent to the White House Office of Management and Budget (OMB) a pair of draft proposed rules that would require reporting of certain information by makers of nanomaterials.  The proposed rules under the Toxic Substances Control Act (TSCA) seemed by all measures to have fallen into a black nano-hole. 

But earlier this week, a smidgen of movement was discernible on the EPA regulatory tracker entry for this long-dormant activity.  What appears to have happened is that EPA has withdrawn the original proposed rules and resubmitted one of them to OMB.  Dropped, apparently, is the proposed significant new use rule (SNUR), which would have required companies proposing to commercialize a nanomaterial for a new use to first notify EPA so that it could conduct a safety review.  Retained is the other half of the original pair of proposed rules, an information reporting rule under the authority of section 8(a) of TSCA.  While details are not yet available, that proposal would require companies currently making nanomaterials to report basic information to EPA.  Read More »

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